PARACETAMOL INJECTION VET.
SHELF LIFE : 24 Months or the expiry date of the active ingredient which ever is earlier.
BATCH NO. :					BATCH SIZE :
MFG. DATE :					PACK SIZE : 30 ml Amber Vials.
EXP. DATE :					LABEL CLAIM : Paracetamol IP ------------------------ 75 mg / ml Benzyl Alcohol IP --------------------- 1.5 % v / v Water for Injection IP ------------------------ q. s.
DESCRIPTION OF THE PRODUCT : A clear colorless solution.
DOCUMENT ISSUED BY : DATE :					DOCUMENT RECEIVED BY : DATE :
ACTIVITY		MANUFACTURING		WASHING & DRYING	FILLING & SEALING		VISUAL INSPECTION		PACKING
COMMENCED ON
COMPLETED ON
PERMISSIBLE YIELD : 90 to 96 %					ACTUAL YIELD
	Minimum		Maximum			In Nos.		In %
30 ml	6,000		6,400		30 ml
Batch manufacturing process is completed as per batch manufacturing record – Yes / No
Deviation sheet attached : Yes / No
FINAL DOC. CHECKED BY : DATE :					FINAL DOC. FILLED BY : DATE :

PREPARED BY

CHECKED BY

AUTHORISED BY

CHECK LIST OF BMR:

Sr. No.	CHECK LIST	CHECKED BY
Sr. No.	CHECK LIST	PROD	QC
1.	Check List of BMR
2.	Raw Material Requisition
3.	Primary Packing Material Requisition
4.	Machinaries And Equipments Cleaning Record
5.	Manufacturing
6.	Intimation for bulk analysis
7.	Filtration
8.	Washing Record
9.	Washing of The Rubber Closure
10.	Filling Record
11.	Secondary Packing Material Requisition
12.	Visual Inspection
13.	Packing
14.	Reconciliation of Packing Material
15.	Reconciliation of the Batch
16.	Rejection Destruction
17.	Master Control Card
18.	Quality Assurance: In Process Check Record
19.	Intimation for Finished Product

RAW MATERIAL REQUISITION

Dispensing Area Clearance: As per SOP No. Mfg. Date:

Exp. Date:

PRODUCTION CHECKS: CERTIFICATION

1. Ensure that Line Clearance to be done as per SOP No. XII.1 ____________

2. Ensure that dispensing both area is “CLEANED” and free from

Previous product. ____________

3. Ensure that weighing balance, scoop, containers are

“CLEAN AND DRY” before weighing. _____________

4. Ensure that “CLEAN” latex hand gloves are worn while

handling raw materials. _____________

5. Ensure that weighing balance checked for zero error before

starting weighing. Error observed ________

Zero adjusted by _______

Notes:

1. Transfer all raw material to mfg. Area through clean container having proper label and store in closed air tight container till taken for manufacturing.

2. Manufacturing should start within 24 hours after dispensing.

Previous Product Dispensed

Batch No.

Completed On

Cleaned By

Checked By

Prod.

Sr. No.	Ingredients	Unit	Item code	Labeled Qty.	Theoretical Qty.	A. R. No.	Actual added	Weighed by	Cked By
1.	Paracetamol IP	kg	R–73	75 mg / ml	15.00		15.000
2.	Propylene Glycol IP	ltr	R–74	----------	100.0		100.0
3.	Benzyl Alcohol IP	ltr	R–5	1.5 % v / v	3.000		3.000
4.	Sodium Metabisulphite IP	Kg	R–77	----------	0.200		0.200
5.	Water for Injection IP	ltr	R–81	q.s.	200		200
6.	Benzyl Alcohol IP	ltr	R–5	----------	0.510		0.510

Raw Material Requisition Raised on: ________________ By: __________________

Material Required on: __________ Material Issued By: _____________On: __________

PRIMARY PACKING MATERIAL REQUISITION

Refer SOP. No.:

Mfg. Date:

Exp. Date:

Sr. No.	Packing Material	P.M. Code No.	Qty. Required	A. R. No.	Qty. Issued	Issued By	Received By
1.	30 ml Amber Vials	P – 16	6,670
2.	Rubber Closure Latex 20mm	P – 28	6,670
3.	Aluminium Seals 20mm T/O	P – 29	6,670

Primary Packing Material requisition Raised on: _______________ By: ________________

Material Required on: ____________ Material Issued By: _____________ On: _________

MACHINARIES AND EQUIPMENTS CLEANING RECORD

Sr. No.	Machine	Cleaned By	Checked By
1.	Manufacturing tank
2.	Filtrate Collection Tank
3.	S. S. Pressure Vessel
4.	S. S. Stirrer
5.	293 mm / 142 mm membrane holder
6.	Washing Table
7.	Filling Table
8.	Aluminium Seal Cap Sealing Machine
9.	S. S. Trays
10.	S. S. Stands

CLEANING RECORD OF ACCESSORIES

Sr. No.	Item	Cleaned By	Checked By
1.	S. S. Spoon
2.	S. S. Buckets
3.	S. S. Container
4.	Filtration & filling Pipes
5.	Filling syringe with filling needle

MANUFACTURING

Previous Product Processed

Batch No.

Completed On

Cleaned By

Checked By

Prod.

STG. NO.	PARTICULARS	OBSERVATION	DONE BY	CHECKED BY
A	MANUFACTURING	Date:
1.	Take, a) Propylene Glycol IP ------------ 100.0 ltr b) Paracetamol IP --------------- 15.000 kg In manufacturing tank take Propylene Glycol IP & dissolve Paracetamol IP in it with constant stirring till we get clear solution.	Qty. _______ ltr Qty. _______ kg Time: From: To:
2.	Take, a) Benzyl Alcohol IP --------------- 3.000 ltr Add & mix in STG No. (1) with constant stirring.	Qty. _______ ltr Time: From: To:
3.	Take, a) Sodium Metabisulphite IP ---- 0.200 kg b) Water for Injection IP -------------- 5.0 ltr Dissolve (a) in (b) with stirring, then transfer this material in manufacturing tank of STG No. (2) with stirring.	Qty. _______ kg Qty. _______ ltr Time: From: To:
4.	Make up the volume upto 200 ltr. With Water for Injection IP.	Vol. _______ ltr
5.	Check pH of the solution. pH limit = 4.0 to 5.5	pH _________
6.	Give the bulk sample to QC for bulk analysis.
7.	On receipt of release report from QC, take the batch solution for filtration.

Sign. of competent tech. Person.

INTIMATION FOR BULK ANALYSIS

Date of Intimation

Mfg.

Date

Exp.

Date

Sampling stage

Intimation given by Prod. Chemist

Sampled

by QC chemist

TEST	RESULTS	LIMITS	INITIALS
Description
pH of the solution		3.5 to 6.0
Assay : Paracetamol IP		95 to 105 %

Conclusion: The sample complies / does not comply with product specification No. 14

Date of issue of PASS / REJECTION slip.

QC Head.

1. Description: A clear, colourless oily solution.

Observation:

Complies/Does not comply.

_________________________________________________________________________________________________

2. Identification: a) 1 mg of test sample in sufficient methanol to produce 100 ml. To

1ml of this solution add 0.5 ml of 0.1M Hydrochloric acid & dilute to 100 ml with methanol. Protect the resulting solution from bright light & immediately measure the absorbance at the maximum at about 249 nm.

Observation:

Spectrophotometer No.:

Limit: Absorbance about 0.44

Complies/Does not comply.

_________________________________________________________________________________________________

b) Boil 2 ml of test sample in 1 ml of Hydrochloric acid for 3 minute, add 10 ml of water & cool, no precipitate. Add 0.5 ml of 0.0167 M Potassium dichromate to above solution. A violet colour develops which does not turn red.

Observation: A violet colour develops/ does not develop which turn/ does not turn red.

Complies/Does not comply.

________________________________________________________________________________________________

3. pH : pH meter No.:

_________________________ (Limit: 3.5 to 6.0)

Complies/Does not comply.

________________________________________________________________________________________________

4. Assay: Take 2 ml of injection, add 50 ml of 0.1N Sodium hydroxide & 100 ml of water. Shake for 15 minute, add sufficient water to produce 200-ml & mix. Take 10 ml of this solution in 100-ml volumetric flask & dilute upto mark with water. Take 10 ml of resulting solution in a 100-ml volumetric flask, add 10 ml of 0.1N Sodium Hydroxide & dilute upto mark with water. Measure the absorbance at 257-nm taking 715 as the value of A (1%, 1 cm).

Observation: Spectrophotometer No.:

Balance No.

Paracetamol: Abs at 257 nm;

Test =

= Test reading x 1000 x 200 x 100 x 100

715 x 100 x 2 x 10 x 10

Limit: 95 to 105 %

Complies / Does not comply.

__________________________________________________________________________________________________

FILTRATION

STG. NO.

PARTICULARS

OBSERVATION

DONE BY

CHECKED BY

FILTRATION

Date:

Use 293 mm / 142 mm presterilised membrane holder containing prefilter of 1.2 µ followed by 0.2 µ membrane filter.

Check the integrity of the membrane filter before & after filtration as per SOP no. VIII.11.

Before filtration

After filtration

Prefilter the bulk through 1.2 µ prefilter followed by 0.2 µ membrane filter using Nitrogen pressure.

Filtration Started at ----------------

Completed at -----------

Collect the filtrate in sterile glass Jar & start filling.

Solution loss during filtration & filling.

Qty.: _________

Sign. of competent tech. person

WASHING RECORD

VIALS WASHING:

WASH THE VIALS IN WASHING SECTION AS BELOW:

1. Soak the vials in 1 % soap solution.

2. Brush each vial on brushing machine and pass over to jetting machine.

3. Vials are jet washed on two head rotary jetting machine by placing vials into vial cups in inverted manner one by one.

4. Adjust the needle position in such a manner that distilled water jet is in the center of the vial so that vial gets washed properly.

Inprocess Checks:

a) Jet position of needle.

b) Clarity of distilled water.

c) Clarity of washed vials.

d) Plate rotations.

Arrange the vials in a tray in inverted position and transfer for dry heat sterilization.

Washing Started at: on:

Date	Quantity Washed	Washing Rejection	Washing Done by	Checked by

Washing Completed at: on:

Sterilization of Vials in DHS:

Temperature : 180°C

Holding time : 2 hrs

Date

Nos. of vials loaded

DHS started at

Sterilization Time

Done by

Checked by

From

Sign of Competent Technical Person

WASHING OF THE RUBBER CLOSURE

A) Wash the rubber closer with 1 % soap solution. Then wash it with purified water till to free from soap.

Time: from: To:

B) Soak the rubber closure in solution of Benzyl Alcohol IP solution.

For 30 ml

Take 17 ltr. Water for Injection IP & dissolve 0.510 ltr Benzyl Alcohol IP stir to get clear solution.

Add the rubber closure & dip well & allow for soaking.

Soaking time – From : date :

To : date :

C) Washing of the rubber closure :

Take soaked rubber closer & wash it with purified water thrice time in rubber closer washing machine, then wash it with distilled water twice.

Date:

Time: from: to:

D) Transfer the washed rubber closures in SS pot with lid & give for sterilization.

E) Autoclaving: at 121ºC / 15 psi for 15 min.

Date

Particulars

Autoclave started at

Sterilization time

Temp.

Pressure

Done by

Cked by

From

Rubber Closures

Membrane Holder

Equipments :

Machine parts,

Silicone tubes,

Filling tank.

Hand gloves

Garments

WASHING OF ALUMINIUM SEALS

Take approximate 1200 Nos. of aluminium seals in a clean plastic crete & wash it with 70 % Isopropyl Alcohol & drain the IPA solution.

Washing done by:

Time:

From: To:

Sign. of competent tech. person.

FILLING RECORD

Take the product for filling only after receiving approval from QC. Fill the product in the vials, plug with 20-mm rubber closure & aluminum seal using filling & sealing machine.

Visually inspect randomly filled & sealed vials for proper sealing & absence of foreign matter at visual inspection table.

Previous Product Processed

Batch No.

Completed On

Cleaned By

Checked By

Prod.

INPROCES CHECKS DURING FILLING

Sr. No.	Parameter	Standards	Frequency	Checked by
1.	Fill volume ( on 3 vials)	For 30 ml : 30.0 to 31 ml	30 minutes	Prod. Chemist
2.	Aluminium cap sealing performance (on 25 vials)	Proper sealing.	30 minutes	Prod. Chemist
3.	Visual inspection (on 25 vials)	Absence of particulate matter.	30 minutes	Prod. Chemist
4.	Clarity	Clarity of solution.	30 minutes	Prod. Chemist

ENVIRONMENTAL CONTROL Check the parameters as per SOP No.

Date	Control checks	Filling & sealing area	Checked by
	Area cleanliness
	Temperature		ºC
Spraying of disinfectant

Filling started at: on:

Date

Time

Volume of the filled vials

Qlty. Of sealing

Operator

Checked by

Filling

sealing

Filling completed at: on:

Total nos. of vials filled :

Nos. of vials rejected :

Nos. of vials filled

(Good, qty. send for pacing) :

Productive hours:

Filling started at	Filling stopped at	Break down	M/C productive hours

Actual filling time:

Total good quantity transferred to quarantine:

Sign. of competent tech. person.

SECONDARY PACKING MATERIAL REQUISITION

Refer SOP. No.:

Mfg. Date:

Exp. Date:

Sr. No.	Packing Material	P.M. Code No.	Qty. Required	A. R. No.	Qty. Issued	Issued By	Received By
1.	Labels	PLB –	7,000
2.	Punching Box	BL – 5	457
3.	Shipper	BL – 6	31
4.	BOPP Tape	BL –16	01

Secondary Packing Material requisition Raised on: ______________ By: ____________

Material Required on: _____________ Material Issued By: ___________ On: __________

VISUAL INSPECTION

To check the visual inspection on visual inspection table as per SOP.

Quantity taken for visual inspection:

Visual Inspection done by:

Visual Inspection started at: on:

Date

Type of rejection

Prod. chemist

Black particle

White particle

Fiber

Glass particle

Volume variation

Sealing defect

other

Visual Inspection completed at: on:

Total rejection:

Quantity transferred for packing:

Sign of competent technical person

PACKING

Start the packing as per SOP.

Packing area line clearance: Date:

Previous Product Packed

Batch No.

Completed On

Cleaned By

Checked By

Prod.

Final packing: Packing started at: on :

Sr. No.	Operation	Date	Operator	Checked by
1.	Gumming of the labels
2.	Vials labeling
3.	Punching box filling
4.	Punching box labeling
5.	Shipper filling, packing & labeling

Packing completed at: on :

Rejection during packing:

Particular	Quantity
Filled vials
Labels
Punching box
Shipper

RECONCILIATION OF PACKING MATERIALS:

Sr. No.	Particulars	Quantity received	Quantity used	Quantity returned to stores	Quantity rejected
1.	30 ml Amber vials
2.	20 mm rubber closures
3.	20 mm aluminium seals
4.	Labels
5.	Punching box
6.	Shipper

RECONCILIATION OF BATCH:

Sr. No.	Particulars	Details	Sign.
1.	Quantity of units filled.
2.	Quantity of units rejected & destroyed.
3.	Quantity of units given for QC analysis.
4.	Quantity of units transferred to BSR including control sample.
5.	Yield = Actual units transferred to BSR X 100 Theoretical units filled ( Limit – 90 % to 96 % )

REJECTION DESTRUCTION: destruction to be done as per SOP No.

Sr. No.

Particulars

Rejected quantity

Quantity destroyed

Destruction date

Checked by

Prod.

30 ml Amber vials

20 mm rubber closures

20 mm aluminium seals

Labels

punching box

Shipper

MASTER CONTROL CARD

PACKING DETAILS			BSR TRANSFER DETAILS
DATE	UNITS PACKED	TOTAL	DATE	UNITS TRANSFERRED	TOTAL




TOTAL			TOTAL

Sr. No.	PARTICULAR	QUANTITY
1.	Quantity transferred to BSR
2.	Bulk sample
3.	I. P. Q. C. samples
4.	Finished samples
5.	Control samples
6.	Other samples
Grand total

% Yield (in liters) = Grand total units X Pack size

1000

PACKING

INCHARGE

APPROVED

CHEMIST

PRODUCTION MANAGER

Q.C.

MANAGER

QUALITY ASSURANCE: IN PROCESS CHECK RECORD

B.No.: Pack size :

Date: Checked by :

O B S E R V A T I O N S

a) Formula card No.: M.F.C. No. 14

Date

b) Steps being carried out

DEVIATION NOTICED :

ACTION RECOMMENDED :

ACTION TAKEN :

c) Description:

e) Fill volume in ml:

For 30 ml = NLT 30 ml.

Date	Time	1	2	3	Sealing Quality	Visual inspection

QUALITY ASSURANCE: IN PROCESS CHECK RECORD

Date e) PACKING :-

Batch Details : -

Batch No. : -

Mfg. Date : -

Exp. Date : -

M.R.P. Rs Inclusive of all Taxes

Mfg. Lic No. 809

Line Clearance : -

Line Identification: -

Observation on the Finished Packs:

Checked at Random packed vials and Shippers

No. of Vials / Shippers

Batch Details tallied on vials labels and shippers.

Clarity of overprinted batch details.

Sealing of vials.

CONCLUSION: The observations of many of the tests carried out are indicative of the fact that the various specifications laid down for this batch has been /not been followed.

Signature / Date. :

INTIMATION FOR FINISHED PRODUCT

Date of Intimation

Mfg.

Date

Exp.

Date

Filled quantity

Quantity

Sampled

Intimation given by prod. Chemist

Sampled

By QC chemist

TESTS	RESULTS	LIMITS	INITIALS
DESCRIPTION		-------
IDENTIFICATION		-------
pH of Solution		3.5 to 6.0
Extractable Volume		For 30 ml: NLT 30 ml
ASSAY : - Paracetamol IP		90 to 110 %
Particulate Matter		----
Sterility Test		----

Conclusion: - The Sample complies / Does not Comply with Product Specification No. STP. 14.

Date of Issue of PASS / REJECTION slip.

Q.C. HEAD

3. Description: A clear, colourless oily solution.

Observation:

Complies/Does not comply.

_______________________________________________________________________________________________

4. Identification: a) 1 mg of test sample in sufficient methanol to produce 100 ml. To 1ml of this solution add 0.5 ml of 0.1M Hydrochloric acid & dilute to 100 ml with methanol. Protect the resulting solution from bright light & immediately measure the absorbance at the maximum at about 249 nm.

Observation:

Spectrophotometer No.:

Limit: Absorbance about 0.44

Complies/Does not comply.

________________________________________________________________________________________________

Observation: A violet colour develops/ does not develop which turn/ does not turn red.

Complies/Does not comply.

________________________________________________________________________________________________

3. pH : pH meter No.:

_________________________ (Limit: 3.5 to 6.0)

Complies/Does not comply.

_________________________________________________________________________________________________

Observation: Spectrophotometer No.:

Balance No.

Paracetamol: Abs at 257 nm;

Test =

= Test reading x 1000 x 200 x 100 x 100

715 x 100 x 2 x 10 x 10

Limit: 90 to 110 %

Complies / Does not comply.

__________________________________________________________________________________________________

5. Sterility Test:

Report No.: ______________________

Complies / Does not comply.

6. Extractable Volume:

1) 2) 3) 4) 5)

6) 7) 8) 9) 10)

Mean:

(Between 30 to 31 ml) Complies / Does not comply.

__________________________________________________________________________________________________

Analyst: Checked by:

ACTUAL YIELD

AUTHORISED BY

CHECK LIST

CLEANING RECORD OF ACCESSORIES

MANUFACTURING

INTIMATION FOR BULK ANALYSIS

Conclusion: The sample complies / does not comply with product specification No. 14

Date of issue of PASS / REJECTION slip.

QC Head.

FILTRATION

FILTRATION

Washing Rejection

WASHING OF ALUMINIUM SEALS

INPROCES CHECKS DURING FILLING

Standards

QUALITY ASSURANCE: IN PROCESS CHECK RECORD

Mfg. Lic No. 809

Checked at Random packed vials and Shippers

INTIMATION FOR FINISHED PRODUCT